shasun company profile
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shasunTRANSCRIPT
INTRODUCTION
COMPANY PROFILE
Shasun Pharmaceuticals Limited (Formerly known as 'Shasun Chemicals and
Drugs Ltd.,') was incorporated in 1976 and is headquartered in Chennai, India. It
manufactures active pharmaceutical ingredients (APIs), their intermediates and enteric
coating excipients with a significant presence in some key generics.
Shasun has created a strong product portfolio, building on its R & D Expertise,
regulatory capabilities and multi scale production capacities. Shasun has also emerged
as a key player in various service segments in the pharmaceutical field besides APIs
and intermediaries, and is strengthening its offer of contract research, custom synthesis,
contract manufacturing and contract formulation services to clients.
Today, Shasun is one of the largest producers of Ibuprofen worldwide. The
company offers derivatives of Ibuprofen like Ibuprofen Sodium, Ibuprofen Lysinate and
S+Ibuprofen. It is also one of the major producers of Ranitidine and Nizatidine in the
world. Its products are exported to countries across North America, Europe, Asia and
Latin America.
Shasun in its endeavour to become a true one-stop shop for global pharma
companies, is evolving its business model to become a complete service provider,
offering services right from the discovery stage to manufacturing formulations. The
company has recently added finished formulations capability as forward integration, and
has invested in large facility to cater to the international regulated market. It has tied up
with multinational companies in the formulations space wherein it will be developing and
supplying products for the US market.
The recent acquisition of the business and facilities of Rhodia Pharma Solutions
by Shasun's wholly owned subsidiary Shasun Pharma Solutions Ltd (SPSL), UK
equipped the company to evolve as a technology based service provider than as a
contract manufacturing and research provider. Its services include innovative process
research and development, rapid response small scale manufacture for clinical trial
supply and full scale commercial manufacture of advanced intermediates and API’s, all
with seamless technology transfer with and without cGMP. The formulation unit at
Puducherry has been approved by US FDA.
By integrating its facilities in India and UK, the company is trying to offer the benefits of operations in
both the countries to its clients. The company has aligned its facilities so that while research can be
conducted in India, development and manufacturing in kilo labs and pilot plant can be conducted either
in UK or India and the optimal mix could be decided based on the regulatory, IP and cost. The company
is planning to set up a multi-product pilot plant facility at Vizag, Andhra Pradesh, focusing on Contract
Manufacturing Services business. In FY06, CRAMS business revenue has reached INR 3430 million.
S. ABHAYA KUMAR Managing Director
S .VIMAL KUMAR Whole Time Director
R .SUNDARA RAJAN Director
M .MOHAN Whole Time Director
S .DEVENDRA Whole Time Director
R .KANNAN Independent Director
N .SUBRAMANIAN Independent Director
CORPORATE OVERVIEW
Today's new medicines are usually the result of collaborations between multi-
skilled teams involved in different parts of the drug life cycle. Modern Pharma or Biotech
companies often partner with companies who specialize in these diverse activities
including: cutting-edge research, medicinal chemistry and biotechnology, process
development, production, validation and regulatory approval for both API and Drug
Product. Rarely are these conducted by just one company. However Shasun has the
ability to offer a wide range of these specialist activities thus allowing the innovative
drug company to reach the market quicker and more cost effectively.
Shasun is engaged in the manufacture of active pharmaceutical ingredients and
drug products with a significant presence in the anti-inflammatory and anti-ulcerative
therapeutic groups. In addition, the company has recently strengthened its offering in
contract research, custom synthesis, contract manufacturing and contract formulation
services through its acquisition of Rhodia Pharma Solutions and offers services and
products to clients in US, Europe and Asia.
Today Shasun exports products to countries across Europe, North America and
others and a wide range of customers from the smallest Biotech to most of the world's
largest Pharmaceutical giants.
Shasun employs more than 1400 people in India, the UK and the US.
Headquartered in Chennai ( India), Shasun operates world-class API facilities at
Cuddalore and Puducherry in South India and Dudley in UK. In the last few years
Shasun has added a state-of-the-art research center in Chennai and a world class solid
oral dosage formulation facility in Puducherry.
Shasun is publicly-held and listed on the National Stock Exchange and the
Bombay Stock Exchange in India.
SHASUN'S HISTORY
From the modest beginning in 1976, Shasun has acquired a worldwide reputation for
the manufacture of Active Pharmaceutical Ingredients (APIs) and their intermediates.
The Company’s products are exported to customers in countries across Europe, North
America, Latin America and Asia.
SHASUN is derived from the name of the founder, Late Shri. Shankarlal Jain and
his wife Smt. Sundarbai.
QUALITY POLICY
We commit to meet National/International Standards and to manufacture and
supply consistent quality Active Pharmaceutical Ingredients, Excipients, Intermediates
and Pharmaceutical Dosage forms to achieve customer satisfaction.
We care, to meet changing customer expectations, to enhance our employee
contributions and to develop and retain our suppliers, in order to sustain our
organizational performance.
We accept responsibilities, to provide conducive work environment for our
employees, to reduce problems and to desist from adversely impacting our
surroundings.
ENVIRONMENT, HEALTH AND SAFETY POLICY
Shasun is committed to protecting the Safety, Health and well-being of its
employees, the community in which we operate and the wider environment.
In achieving this aim we will:
Comply with all applicable legal and other requirements.
Operate with the principles of Responsible Care and continually strive for
excellence.
Continually review and improve our processes, services and products to
reduce industrial risk and impacts.
Educate, train and motivate employees to conduct their activities in a safe
and environmentally responsible manner.
Use resources efficiently and minimize waste utilizing pollution prevention
techniques.
Work with suppliers and partners to mutually improve EHS performance.
Integrate our sites effectively into their natural environment and local
communities.
INFORMATION SECURITY POLICY
Shasun committed to protecting the confidentiality, integrity, and availability of
information entrusted to itself by its staff, suppliers and other partners, as deemed
necessary by privacy obligations, regulatory compliance or contractual obligation. To
meet this vision we will develop, implement, and maintain most current information
security standards, procedures, and best practices.
The objectives of the organization towards Information Security are:
Set direction in achieving safe and secure environment and security of
information to users.
To maintain the Confidentiality, Integrity and Availability of the information.
To manage Shasun’s Information security using Risk Management framework
with a criteria for evaluating the risk based on the impact on confidentiality,
integrity and availability.
To maintain high awareness levels of security policies as applicable to various
roles, through training and awareness campaigns.
Comply with legislative and contractual requirements.
Security incident management and prevention.
Continuous improvements in security management through Security Forum.
Protect Shasun’s Intellectual property rights and proprietary information.
Business continuity management through formulation and periodic testing of
business continuity plans.
Shasun has selected to dovetail its strategic blueprint with the business growth being
projected by its partners. It has extended this from a one-off instance to an ongoing
commitment through the following priorities:
An effective combination of scale, competence and costs in all business
investments with the objective of achieving value-addition.
An ongoing presence in regulated markets with the objective to enhance
capability and profitability, setting off a virtuous cycle.
A prudent leverage in organic synthesis, process development, supply chain and
world-class facilities with the objective to emerge as a trusted outsourcing partner
for key innovator companies.
A focus on long-term relationships with the objective to grow customer accounts
and generate attractive referral business.
An emphasis on an increasingly professional management with the objective to
scale up the business in a continuous way in response to growing opportunities.
A stated non-competing approach with customers with the objective to enhance a
sense of trust.
QUICKER TURNAROUND TIME
Shasun possesses the ability to extend projects from lab to validation within 12
months, and from shell to operations within six months.
A judicious provision of buffer capacity permits the company execute critical projects with speed.
COMPETITIVE PRICING
Shasun enjoys India’s inherent advantage of low project and labour costs,
leading to cost-effective customer solutions.
This is reinforced by the capability of its development chemistry group to develop
efficient alternative processes within costs and deadlines
The company’s experienced scale-up team helps migrate lab projects to successful product development
CORE STRENGTHS
High quality, cGMP production.
Continuous process innovation.
Strong MNC relationships in API supply, contract manufacturing and contract
research.
Deep regulatory capability.
Richly experienced and professional team.
Successful R&D initiatives in the development of non-infringing processes for generic APIs and intermediates
PHILOSOPHY
Research & Development for the Pharmaceutical Industry – From Service
to Solution Provider
Shasun looking for long-term collaborations
Shasun prefer to grow by adding value to collaborators
PRODUCTS
Carisoprodol
Ketoprofen
Sevelamer Hydrochloride
Sevelamer Carbonate
Methohexital
Meprobamate
Gabapentin
Olanzapine Form-I
Isradipine
Quinapril Hydrochloride
Colesevelam Hydrochloride
Lacidipine
Cycloserine
Chlorphenesin
Ranitidine Base
Nizatidine
Diphenhydramine citrate
Z-L-Cyclohexylglycine
Z-L-tert-Leucine (dicyclohexylammonium) salt
BRANDED FORMULATION
WARFEN
WARFEN is used for the prophylaxis and or treatment of the thromboembolic
complications associated with a trial fibrillation and or cardiac valve replacement.
WARFEN is also used for the treatment of Venous Thrombo embolism and pulmonary
embolism.
WARFEN tablets are used to reduce the risk of death and recurrent myocardial
infarction
GLIMSEN
GLIMSEN is indicated as an adjunct to proper dietary management, exercise and
weight reduction to lower blood glucose in patients with type 2 diabetes whose
hyperglycemia cannot be controlled by diet and exercise alone.
GLIMSEN has low risk of hypoglycemic.
GLIMSEN has potent blood -glucose lowering effect with less stimulation of
insulin secretion, possibly due to more pronounced extra pancreatic effects.
GLIMSEN has lower dosage, rapid onset and long duration of action
GLIMSEN can be used in combination with Metformin, the thiazoliinodiones,
alphaglucosidase inhibitors and insulin.
FORMULATION
Shasun Pharmaceutical Division develops and manufactures formulations for solid
dosage products. The Division is a vertically integrated formulations partner for the
pharmaceutical industry. Its services include formulation research and development
activities, Analytical method development and validation, scale-up and technology
transfer, clinical supplies manufacturing to full scale commercial manufacturing of oral
solid dosage forms.
The formulation facility is located in Puducherry, in the south eastern coast of India. The
site is located on a 14 acre campus with plenty of room for future expansion.
It is a new facility completed in 2006 with 100,000 square feet of constructed space. It
contains office areas, analytical laboratories, formulation development laboratories, a
cGMP pilot plant and commercial manufacturing space. The facility is built to meet the
regulatory requirements of the US FDA, Health Canada, MHRA in the U.K and other
European Agencies.
Some of the key features include separate air handling units with terminal mounted
EU13 HEPA filters, to provide a class 100000 environment in the manufacturing areas.
These are continuously monitored by a building automation system. Tablet compression
areas have vertical material flow to avoid cross contamination. Automatic container
cleaning system ensures validation of cleaning procedures.
The facility has limited access controls and CCTV monitoring of man movement to
various areas inside the facility, to avoid violation of current Good Manufacturing
Practices (cGMP).
CONTRACT FORMULATION
Shasun Pharmaceutical Division contract manufactures finished oral dosage
forms for a number of Pharmaceutical companies worldwide. These include film coated,
sugar coated and enteric coated tablets as well as hard gelatin capsules
Our granulation technologies include both low and high shear wet granulation
processes as well as direct compression granulation. We use fluid bed granulators and
driers to produce the granules.
Tablet compression machines are capable of manufacturing single as well as bi-
layer tablets and our coating technology includes film, sugar and enteric coated tablets
as well as pellets for encapsulation.
Our Packaging capabilities include bottle and blister packaging as well as bulk
granules. Blisters can be packaged cold and hot form materials. The final finished
product can be packaged and labeled as per regulatory requirements and ready for
delivery to the customer.
BIOTECHNOLOGY
Shasun recognizes the role of biotechnology as the future of the global
pharmaceutical industry in enhancing therapeutic effectiveness, improving lifestyle
quality and strengthening corporate profitability. In view of this, the company is involved
in the creation of significant biotechnology capabilities & capacities especially in the
area of protein processing solutions to provide services for the biotech &
pharmaceutical companies
EMPLOYEE DEVELOPMENT
Shasun is a FDA approved company for manufacture of bulk pharmaceuticals
and hence the practices are equal to the best pharmaceutical companies in India and
across the world. Being an ISO 9001:2000 certified company only supports the strength
of our quality systems providing every employee with the best work standards.
Shasun provides also congenial atmosphere to work, learn and grow. The
company conducts various programmes to train their staff in the latest technologies and
best management practices by organizing regular training classes keeping in mind the
needs of each individual, and also encourages its employees to participate in industry
events and trade shows.
Shasun’s R&D centre is a recognized the by Madras University as an institute for
pursuing doctoral programme in chemistry. Young chemists are motivated to work on
weekends on research projects, supervised by their guides, in subjects of their
academic interest, which are discovery oriented and not purely commercial projects.
SHASUN CULTURE
We are in transition from being a family owned and managed company to a organization
run by qualified professionals. New leadership has taken charge within and the effect is
a rejuvenated new culture. Every Shasun employee is today encouraged to become a
leader by taking ownership for actions in their respective work areas. Cross-functional
understanding and interaction within various departments and sites is required.
TRAINING AND DEVELOPMENT
Shasun is a FDA approved company for manufacture of bulk pharmaceuticals
and hence the practices are equal to the best pharmaceutical companies in India and
across the world. Being an ISO 9001:2000 certified company only supports the strength
of our quality systems providing every employee with the best work standards.
Our clientele is multi-national and hence more opportunities for travel,
interaction, and understanding of international culture and standards involved is
available to our employees, which groom them to become a world leader.
Shasun provides also congenial atmosphere to work, learn and grow. The
company conducts various programmes to train their staff in the latest technologies and
best management practices by organizing regular training classes keeping in mind the
needs of each individual, and also encourages its employees to participate in industry
events and tradeshows.
Shasun’s R&D centre is a recognized the by Madras University as an institute
for pursuing doctoral programme in chemistry. Young chemists are motivated to work
on weekends on research projects, supervised by their guides, in subjects of their
academic interest, which are discovery oriented and not purely commercial projects.
SHASUN PH D PROGRAM
In-house Ph D Program: Shasun R&D has been recognized for the Ph.d
program of Madras University & Anna University. Shasun R&D centre has started
recently an in-house PhD program to promote and enhance the capability of our
scientists and to also get into basic research activities in related topics of interest of
Shasun. One of our employee, Ms. Suman Meenakshi, have been registered with Anna
University for the Ph.D. program. Mr.Karthikeyan has registered for Ph D programme
for Madras University. This year two more employees will be registered for the PhD
program of Anna University. SRC intend to expand this program and extend it to more
than one university in the future.
MILESTONES
1976-1990
Incorporated as a private limited company, Shasun Chemicals in Chennai
First production facility established at Velachery, Chennai, for manufacture of
Analgin (antipyretic).
Second production facility was established at Puducherry for manufacture of
Ibuprofen (anti-inflammatory)
1990-2000
Third manufacturing unit set up at Cuddalore to manufacture the anti-ulcerative
Ranitidine HCI
Shasun converted into a public limited company, incorporating its present name.
US subsidiary, Shasun Inc., is established
The company's shares were listed on Mumbai, Ahmedabad and Chennai stock
exchanges.
Technology and joint marketing agreement signed with Nagase & Co., Japan for
S+Ibuprofen
The company signed a technology agreement with Chircotech, UK, for
S+Naproxen.
The company signed a joint venture agreement with Austin Chemical Company, USA,
2000-2010
The company's exports exceeded Rs.100 cr.
Established a biotech laboratory in its R&D centre.
Signed a letter of intent with Eli Lilly for supply and manufacture of an anti-TB
drug.
Multi Purpose Plant at Cuddalore was commissioned.
Completed setting up its new Research Centre.
Strategic partnership with Glenmark and Alpharma(now part of Actavis) for
Development & Supply of Formulation products.
Completed its first ever acquisition of Rhodia Pharma Solutions business
marking its advent in the Global supply arena
Successful maiden inspection of the formulation unit by US FDA authorities in
Pondicherry (Puducherry).
Successful completion of the US FDA inspection of its Cuddalore and UK
facilities (Annan and Dudley).
Received certi?cation of ISO 27001 (ISMS-Information Security Management
Systems) by Bureau Veritas.
Signed a licensing agreement with Gilead for manufacture of Viread to support
the Clinton Foundation initiative
Licensing of cross-coupling technology (Buchwald Technology) to H-Lundbeck
A/S and Merck & Co. Inc.
Setting up of Lab facility at Piscataway (New Jersey), United States to provide
API development service in pre-clinical and clinical trial stages.
Embarks on implementation of an enterprise resource planning (ERP) - SAP
across all its locations.
Successful completion of clinical trials of “Streptokinase”, a biotech product.
Successful completion of US FDA re-inspection of formulation unit at
Puducherry.
Closure of Annan plant at Scotland, UK and operations consolidated at Dudley
facility.
Commercial Launch of Recombinant Streptokinase in the Indian Market in June
2009.
Initiation of Toxicity Studies with respect to GCSF and PEG-GCSF - biotech
products.
Received commercial order of a leading API product from an Innovator Company
(an anti depressant drug).
Achieved leadership position in API product - Gabapentin (?nds application for
anti epileptic cases).
Finished Dosages sales has grown by 100% as compared to FY09 and has crossed Rs 50 crores in turnover in FY10.
2011
Formed 50:50 Joint Venture “SHASUN NBI LLC” in USA with Nanoparticle
Biochem Inc. for development of proprietary process of nanoparticles used in
therapy & medical diagnostics.
Commercial launch of Olanzapine API in Europian and North American
markets.